(57 days)
The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
The Monarch Platform is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform enables robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator. The Monarch Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera.
The Monarch Platform consists of three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the robotic arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The flexible Monarch Bronchoscope has a working channel and a camera at the tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.
Additionally, the Monarch Platform includes electromagnetic (EM) navigation that integrates a pre-operative computed tomography (CT) scan into an intra-operative interface. displaying the modeled bronchoscope tip location relative to the preoperative scan anatomy. Two options of field generators are available to enable electromagnetic navigation. The current Monarch Navigation Field Generator and a new Window Field Generator (WFG). The new WFG is being added to increase compatibility of the Monarch system with advanced imaging systems (Cone Beam and Mobile CT).
Here's an analysis of the provided text regarding the Monarch Platform's acceptance criteria and study information:
Device Acceptance Criteria and Performance Study Analysis
The document describes the Monarch Platform, a robotic bronchoscopy system. The premarket notification (K211493) focuses on modifications to an existing cleared device (K193534), specifically the introduction of a "Window Field Generator (WFG)" as an optional accessory and minor software changes. Therefore, the performance data presented is primarily to demonstrate that these changes do not raise new questions of safety or effectiveness compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of quantitative acceptance criteria with specific thresholds (e.g., accuracy > 95%). Instead, it generally states that the device was tested to ensure it performs "as intended" and that changes "do not raise different questions of safety or effectiveness."
Here's a summary of the reported device performance based on the general statements:
| Aspect Tested | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall System Performance | Performs as intended, no new safety/effectiveness questions raised by modifications. | "Overall, device performance testing showed that the differences in technological characteristics do not raise different questions of safety or effectiveness." |
| Electrical Safety | Meets relevant electrical safety standards. | "Verification testing included electrical safety..." |
| Electromagnetic Compatibility (EMC) | Meets relevant EMC standards. | "...and electromagnetic compatibility..." |
| Software Functionality | Software changes operate correctly and do not introduce new risks. | "...software, and performance specifications verification testing." (Specifically mentions "minor software changes" including arm kinematics, smoother virtual views, new 'Segmentation Failure' notification trigger, and reduced red saturation in live endoscopy view.) |
| Window Field Generator (WFG) Functionality | Performs the same function as the existing Monarch Field Generator, with increased mechanical compatibility. | "This new WFG has the same core technological characteristics as the current Monarch Field Generator but is secured under the patient bed to optimize mechanical compatibility. Both EM field generators perform the same function for the Monarch Platform." |
| Clinical Input Requirements (CIR) | Meets defined CIRs for its intended use. | "confirmatory validation testing was performed to ensure the device meets its Clinical Input Requirements (CIR) for its intended use." |
| Impact on Workflow | Modifications do not negatively impact the pertinent parts of the workflow. | "Validation Testing included evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists." |
2. Sample Size and Data Provenance
The document does not specify the sample size used for the test set. It mentions "evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists," but provides no numbers for patients, cases, or procedures.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. Given the context of a 510(k) submission for a medical device cleared in the U.S., it's highly likely the data would come from U.S. clinical settings, but this is an inference.
3. Number and Qualifications of Experts
The document states that "accredited bronchoscopists" were involved in the "Validation Testing including evaluations of the pertinent parts of workflow." It does not specify the number of experts or their years of experience/specific qualifications beyond being "accredited bronchoscopists."
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or for establishing ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention is made of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study described focuses on verifying the safety and effectiveness of device modifications rather than assessing the AI's impact on human reader performance.
6. Standalone Performance (Algorithm Only)
The document does not explicitly state that a standalone (algorithm only without human-in-the-loop performance) study was done for the navigation updates. The "navigation was updated for smoother virtual views when transitioning between predicted airways" and "An additional condition for which a "Segmentation Failure" notification would be triggered" suggest algorithm internal testing, but no formal standalone performance study results are provided in the summary. The Monarch Platform is an integrated robotic system where the navigation is an aid to the physician, not a standalone diagnostic tool.
7. Type of Ground Truth Used
The type of ground truth for the device's performance, particularly for the navigation and segmentation aspects, is not explicitly defined. However, given the context of bronchoscopic visualization and access, the "ground truth" for the device's ability to maintain its intended function would likely involve:
- Imaging data: Pre-operative CT scans are used for EM navigation, and live endoscopy views provide real-time visualization.
- Expert assessment: "Accredited bronchoscopists" evaluated workflow, implying their professional judgment against clinical standards would serve as a form of ground truth for usability and functional performance.
- Engineering specifications: Performance verification against design specifications would constitute a ground truth for many technical aspects.
Pathology or extensive outcomes data are not mentioned as being used for the performance testing described.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. This is because the submission is for modifications to an already cleared device, and the focus is on verification and validation of the changes, not a de novo AI algorithm development where training data would typically be detailed.
9. How Ground Truth for the Training Set Was Established
Since no training set information is provided, there is no information on how its ground truth would have been established.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.